A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban as Anticoagulant in Patients With Extracorporeal Membrane Oxygenation (ECMO)
Overview
- Phase
- Phase 2
- Intervention
- Argatroban
- Conditions
- Extracorporeal Membrane Oxygenation Complication
- Sponsor
- Medical University of Vienna
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This prospective, randomized, controlled pilot trial aims to assess the safety and feasibility of Argatroban as an alternative anticoagulant to unfractionated heparin in patients receiving extracorporeal membrane oxygenation.
Investigators
Thomas Staudinger
Prof., MD
Medical University of Vienna
Eligibility Criteria
Inclusion Criteria
- •Minimum Age 18 years
- •VV- or VA-ECMO therapy
- •Minimum of 24h planned ECMO-therapy
Exclusion Criteria
- •History of Heparin-induced thrombocytopenia (HIT)
- •High risk of bleeding, contraindication for anticoagulation (eg. active GI-bleeding, Intracerebral bleeding; Platelet count \<50G/l, congenital bleeding disorder)
- •Pregnancy
- •Severe Liver disease (SOFA score liver domain 4 points = Bilirubin \>12mg/dl)
- •Postoperative admission
- •Strong lupus anticoagulant or acquired intrinsic clotting factor deficiency at admission (APTT \>50 sec without anticoagulation).
Arms & Interventions
Argatroban
Continuous infusion of 0,3μg/kg/min to target an aPTT of 50-70sec and/or Hemoclot of 0,60 - 0,80 µg/mL
Intervention: Argatroban
Unfractionated Heparin
Continuous infusion of Unfractionated Heparin to target an aPTT of 50-60 seconds and/or Anti-Xa level between 0.20 and 0.30 IU/ml and/or thrombin time \>20sec.
Intervention: Unfractionated heparin
Outcomes
Primary Outcomes
Bleeding and thrombosis with Argatroban compared to unfractionated Heparin (UFH)
Time Frame: From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days
Bleeding will be assessed continuously by the investigators according to the BARC bleeding classification, where bleeding type 2 or higher will be considered as clinically significant bleeding; outcome measures will be the incidence of clinically significant bleeding per ECMO day and time to first bleeding; thrombosis is defined as any occurence of thromboembolism including membrane lung exchange due to suspected thrombosis, pulmonary embolism or deep vein thrombosis; outcome measures will be the incidence of thromboembolism per ECMO day and the time to first thromboembolism
Secondary Outcomes
- study enrollment, study completion and ability to achieve target values of Argatroban as anticoagulant in ECMO(From date of randomization until the date of ECMO discontinuation, or death, whichever came first, assessed up to 120 days)